Performance Verification of LP(a)Reagents in Clinical Laboratory / 现代检验医学杂志

ABSTRACT

Objective To validate the analytical performance of four LP(a)reagents with Immunoturbidimetry method used on the automatic biochemistry analyzer for preliminary clinical application.Methods The performance of four LP(a)reagents (labeled as A,B,C,D)with method from RANDOX,Zhejiang Kuake Co.,Beijing Leadman Co.and Beijing Jiuqiang Co.on Olympus AU5800 automatic biochemistry analyzer were assessed.The precision,linearity range,accuracy,disturbance (vita-min C,bilirubin,hemoglobin,TG)were assessed.Results The within-run CVs of the four reagents (A,B,C and D)were 0.64%~1.18%,3.59%~4.75%,1.33%~3.05% and 1.43%~2.01% respectively.The between-run CVs in A,B,C and D were 1.04%~1.7%,3.81%~4.93%,2.16%~4.76% and 2.33%~3.21% respectively,lower than the stated.The lin-earity range was 82~923 mg/L (r2 =0.997),130~935 mg/L (r 2 =0.996 4),120~1025 mg/L (r 2 =0.992 1)and 117~943 mg/L (r2 =0.999 5)in the four reagents,which demonstrated a sound linear correlation.For interference tests,no re-markable interferences (<±10%)of reagent A and reagent D were detected when Vitamin C≤10 mg/dl,hemoglobin≤200 mg/dl,bilirubin≤40 mg/dl and TG≤500 mg/dl.Interference of reagent B was found when VC≥5 mg/dl,TG≥250 mg/dl and when TG≥250 mg/dl reagent C was interfered significantly.The four LP(a)reagents were used to detect the lipid con-trol,and the deviations of the target value were - 8.07%,1.34%,- 8.05% and 7.38% respectively.Conclusion When used in automatic biochemical analyzer,the four LP(a)reagents showed high precision.The four reagents are all able to meet clinical test requirements,nevertheless,anti-interference capability were different.